FDA Safety Notification: Risk of Eye and Skin Injuries from High-powered, Hand-held Lasers Used for Pointing or Entertainment

Purpose: The Food and Drug Administration (FDA) is alerting consumers about the risk of eye and skin injuries from high-powered laser pointers.

Summary of Problem and Scope:

The Food and Drug Administration (FDA) is alerting consumers about the risk of eye and skin injuries from exposure to high-powered laser pointers. FDA regulations limit the energy output of hand-held laser pointers to 5 milliwatts (mW).

Although illegal and potentially dangerous, they are increasingly available on the Internet and in stores. The FDA wants to make consumers aware that they should not buy these lasers for themselves or as gifts for others.

Even at the 5mW legal limit, when lasers are aimed directly into the eye, they will cause temporary flash blindness. This will not likely cause permanent injury, because most people have a protective reflex to look away, blink, or make other involuntary movements to protect the eyes. However, reflections of the laser beam from mirrors or metallic surfaces may not induce the protective reflex quickly enough to avoid injury, and intentionally keeping your eyes open and staring into a 5 mW beam will cause eye injury.

Lasers that emit more than 5mW output power can cause irreversible eye injury of increasing severity with increased output power. These high-powered laser pointers can irritate or even burn the skin.

The FDA believes that many eye injuries from laser pointers go unreported. Nonetheless, the FDA is aware of laser pointer radiation incidents involving military personnel, researchers, and public speakers. The number of eye injuries in children resulting from playing with laser pointers is increasing. The FDA is aware of three incidents reported in the media among children in 2010.

The FDA is also aware of incidents reported by the Federal Aviation Administration of pilots experiencing temporary flash-blinding when lasers are aimed at their aircraft. The temporary loss of vision reported by pilots during these incidents could cause a serious accident. In 2009, pilots reported a total of 1500 incidents of light beams striking their aircrafts or illuminating their cockpits, the majority of which were from laser light. In the first 10 months of 2010, 2321 incidents were reported. Using a laser to illuminate aircraft is a federal crime. Individuals convicted of shining either legal or overpowered lasers on an aircraft are subject to fines and may be sentenced to prison time due to the seriousness of such crimes.

Other incidents that the FDA is aware of include:

A child’s eyes were damaged from reflected beams after directing a150 mW laser pointer into a mirror.

A California man was convicted and sentenced to 15 months in federal prison for shining a laser pointer at a police helicopter, causing the pilot to suddenly look away and change direction.

In its August 2010 press release, the Laser Institute of America warned the public of the hazards of relatively inexpensive 1000 mW blue lasers (995 mW over the legal limit) available from an internet retailer. As high-powered laser pointers become more affordable their availability increases along with the chance that injuries will occur.

FDA Enforcement:

The FDA regulates laser product manufacturers and sets performance standards for lasers to protect the public from laser radiation. The sale of lasers which do not meet these standards is illegal in the United States. Domestic and foreign laser manufacturers are subject to FDA inspections or targeted investigations to identify unsafe or non-compliant laser products. Laser products imported into the U.S. are inspected by U.S. Customs and Border Protection with FDA cooperation.

Manufacturers that fail to comply with FDA’s requirements are subject to regulatory action. Regulatory actions may include requiring recalls of unsafe products or detaining such products upon import to the U.S. For example, several foreign manufacturers produce and sell laser pointers with an output greater than 5mW and have been placed on Import Alert, which identifies their products for automatic detention by FDA when they enter the U.S. Some foreign manufacturers attempt to avoid U.S. Customs and FDA oversight, but FDA continues to conduct various actions to prevent the entry of illegal laser products into the U.S.

Recommendations:

The FDA recognizes that there are varied and legitimate uses of laser pointers, including giving presentations, aligning and leveling in construction, providing gun sights, and pointing to stars. Even lasers under the 5mW limit can cause harm if not used properly. The FDA recommends the following:

Do NOT buy laser pointers for children or allow them to use them. These products are not toys.

Do NOT buy any laser pointer that emits more than 5 mW output power and does not have the output power printed on the warning label affixed to the pointer. Hand-held laser pointers over 5 mW and those that are not properly labeled are illegal and potentially dangerous.

Do NOT aim or shine laser pointers at any person, pet, vehicle, or aircraft directly, or through reflection by mirrors or other shiny surfaces.

Check the output power of any laser pointer that you own. If it has an output greater than 5 mW, dispose of it safely according to local environmental protection guidelines.

In the event of injury, immediately consult your eye doctor.

Report Problems to FDA:

Prompt reporting of injuries can help FDA identify and lessen the risks associated with these products. If you have been injured by a laser pointer, or if you witness an injury involving a laser pointer, we encourage you to submit a report to the FDA District Office consumer complaint coordinator for your geographic area.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.